With recent market globalization, the production sites of manufacturing industries have spread worldwide. In the pharmaceutical field, clinical development proceeds concurrently in a plurality of countries by the exploitation of global clinical trials. New drug application, approval, and marketing are now performed in almost the same timing around the world.
In the case of manufacturing the same product at a plurality of manufacturing sites, it is important to ensure constant product quality by setting specifications. Since medicinal products are controlled under strict specifications, an applicant must set specifications for each product to be approved and undergo review of the specifications for their appropriateness by regulatory authorities. In general, whether products comply with the approved specifications is assessed by end-product testing of the final products. Recently, a method based on real-time release testing using data obtained in the manufacturing process has been proposed as quality testing to assess approval or non-approval for the shipment of end products. Real-time release testing eliminates end-product testing of the final products and therefore permits immediate shipment after manufacture. Examples of descriptions of approval application forms relating to real-time release testing in pharmaceutical development have been published (Non-patent Literatures 1 to 4). Nonetheless, they have been applied in only a few cases of actual new drug application.
In the case of manufacturing the same product at a plurality of manufacturing sites, large differences in the quality of available raw materials, manufacturing scale, the type of manufacturing equipment, the skill of personnel in charge of manufacture, etc. must be taken into consideration. At each manufacturing site, process parameters such as manufacturing equipment parameters, temperature, and/or reaction time must be adjusted according to its equipment or environment in order to achieve the required specifications for the end-product.